FDA Device recall Z-0955-2015
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console),…
- FDA Device
- Class II
- terminated
- Published 2015-02-04
On 2015-02-04 the FDA classified a Class II recall of The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console),… by Ge Healthcare, citing A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0955-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-12 |
| Published | 2015-02-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | CA, FL, IL, NY, UT, WA |
Product
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
Reason
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
Identifiers
| code_info | Software version: 14MW14.29 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0955-2015%22
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